REDEFINE THE TREATMENT OF MILD-MODERATE GLAUCOMA WITH ITRACK

Combining a process of 360° catheterization and pressurized viscodilation of Schlemm’s canal, iTrack™ is a tissue-sparing and restorative MIGS procedure that can effectively reduce IOP and the medication burden in patients with mild-moderate glaucoma, while also preserving future treatment options.

I view the angle as the new conjunctiva, because I want to manipulate it today – but I also want to preserve tissue. We all know that there’s not a single glaucoma procedure that lasts forever. I want to be able to come back and treat the patient again.

RE-ESTABLISH THE CONVENTIONAL OUTFLOW PATHWAY WITH iTRACK™ — AND REDUCE IOP AND MEDICATION BURDEN

iTrack™ ab-interno canaloplasty comprehensively addresses all resistance sites in the conventional outflow pathway, including the collector channel ostia, to effectively reduce IOP and medication dependence without causing any physiological changes, and without leaving behind a stent or shunt. iTrack™ is suitable for both phakic and pseudophakic patients.

iTrack™ achieves post-op
IOP in the mid-teens

Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clinical Ophthalmology. Vol 12. August 2018.

iTrack™ reduces the number of medications by up to 50%

Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clinical Ophthalmology. Vol 12. August 2018.

iTRACK™ TREATS ALL SITES OF OUTFLOW RESISTANCE IN THE CONVENTIONAL OUTFLOW SYSTEM — BOTH PROXIMAL AND DISTAL

iTRACK™ CAN EFFECTIVELY REDUCE HERNIATIONS INTO THE COLLECTOR CHANNELS

Research by Gong et al demonstrated that up to 90% of collector channels were blocked by herniations of the trabecular meshwork in POAG eyes. These herniations into the collector channels result in increased outflow resistance.

  • 360° catheterization pushes herniations out of the collector channels to reduce outflow resistance.
  • Pressurized viscodilation dilates the collector channels to improve outflow.

iTRACK™ CAN INCREASE THE DIAMETER OF SCHLEMM’S CANAL

Pre-iTrack: canal is collapsed
Post-iTrack: canal is open

The dimensions of the lumen of Schlemm’s canal are smaller in POAG eyes, resulting in increased outflow resistance.

  • 360° catheterization mechanically breaks adhesions within Schlemm’s canal to restore a more patent architecture to the canal. 
  • Pressurized viscodilation dilates the canal to reduce outflow resistance.

Not only does iTrack™ break the herniations that we see in the canal, but it also viscodilates. So, it’s really pushing out the entire distal channel and also opening up the trabecular meshwork.

Polymer shaft and distal atraumatic tip
Optical fiber, light transition
Lumen
Internal guide wire
Ultra-thin, flexible 0.5mm diameter optical fibre

The iTrack™ canaloplasty microcatheter is the only device cleared by the FDA (510k) for viscodilation of Schlemm’s canal

GREATER VOLUME OF OVD DELIVERY

The iTrack™ canaloplasty microcatheter delivers more than 100 microliters of OVD over 360° of Schlemm’s canal* via a series of precise, surgeon-controlled aliquots. As observed via blanching of the episcleral veins immediately following the procedure4, iTrack™ ab-interno canaloplasty improves flow through the entire conventional outflow system, including the distal outflow system.

* Testing using a robotically controlled ViscoInjector™ with time-recording mass data to simulate the delivery of OVD over 360° of Schlemm’s canal. Data available upon request


PRESSURIZED VISCODILATION

The iTrack™ canaloplasty microcatheter is the only device to deliver OVD into Schlemm’s canal via a patented, pressurized mechanism (Patent No. US7,967,772,B2) in order to stretch the trabecular meshwork and to create microperforations into the anterior chamber, and to push out herniations of the collector channel ostia.


SURGEON-CONTROLLED OVD DELIVERY

With the iTrack™ canaloplasty microcatheter you can adjust the volume of OVD delivered based on the patency of Schlemm’s canal to deliver more, or less, OVD as required.


INTELLIGENT NAVIGATION

A malleable yet rigid internal guide wire within the iTrack™ canaloplasty microcatheter minimizes the risk of creating an artificial pathway. It also enables you to push through herniations and to maneuver through tight areas of the canal.


PROPRIETARY ILLUMINATION

A proprietary illuminated fiber optic tip provides continuous location feedback and helps to safeguard against misdirection of the iTrack™ canaloplasty microcatheter into the suprachoroidal space or the collector channels. 

What’s so nice about iTrack™ is the fact that we can control how much viscoelastic we’re pushing into Schlemm’s canal, and to see distension of the canal by up to two or three times.

Visit the iTrack™ website
Glaucoma-iTrack.com

References
1. Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clinical Ophthalmology. Vol 12. August 2018
2. Körber N. Ab interno canaloplasty for the treatment of glaucoma: a case series study. Spektrum Augenheilkd (2018) 32:223227
3. Gallardo MJ, Supnet RA, Ahmed IIK. Circumferential Viscodilation of Schlemms Canal for Open-Angle Glaucoma: ab-interno vs ab-externo canaloplasty with tensioning suture. Clinical Ophthalmology 2018:12 24932498.
4. Lubeck DM, Singh IP, Noecker RJ. Evaluation of Endothelial Cell Density and Loss Following iTrack Ab-Interno Canal Based Surgery. ASCRS 2020 (Paper Presentation). https://​ascrs​.con​fex​.com/​a​s​c​r​s​/​20​a​m​/​m​e​e​t​i​n​g​a​p​p​.​c​g​i​/​P​a​p​e​r​/​68712
5. Lewis RA, von Wolff K, Tetz M. et al. Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. J. Cataract Refract. Surg. 37, 682 – 690 (2011).
6. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322.
7. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504.
8. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.
9. Fellman RL, Grover DS. Episcleral venous fluid wave: intraoperative evidence for patency of the conventional ouflow system. J Glaucoma. 2014;23(6):347 – 350.
10. Gong H, et al. Reduction of the available area for Aqueous humor outflow and increase in meshwork herniations into collector channels following acute IOP elevation in bovine eyes. Invest. Ophthalmol Vis Sci 2008; 49:5346 – 5352.
11. Gong H and Francis A: Schlemm’s Canal and Collector Channels as Therapeutic Targets. In Innovations in Glaucoma Surgery, Samples JR and Ahmed I eds. Chapter 1, page 3 – 25, Springer New York, 2014.
12. Allingham RR, de Kater AW, Ethier CR. Schlemm’s canal and primary open angle glaucoma: correlation between Schlemm’s canal dimensions and outflow facility. Exp Eye Research 1996;62:101 – 10
13. Maepea O, Bill A. Pressures in the juxtacanalicular tissue and Schlemm’s canal in monkeys. Exp Eye Res1992;54:879 – 883.


The iTrack™ canaloplasty microcatheter is the only device indicated for viscodilation in the treatment of open-angle glaucoma. 

Indications: The iTrack™ canaloplasty microcatheter has been cleared for the indication of fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.

Contradictions: The iTrack™ canaloplasty microcatheter is not intended to be used for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in eyes of patients with the following conditions: neovascular glaucoma; angle closure glaucoma; and, previous surgery with resultant scarring of Schlemm’s canal.

Adverse events: Possible adverse events with the use of the iTrack™ canaloplasty microcatheter include, but are not limited to: hyphema, elevated IOP, Descemet’s membranedetachment, shallow or flat anterior chamber, hypotony, trabecular meshwork rupture, choroidal effusion, Peripheral Anterior Synechiae (PAS) and iris prolapse.

Warnings: The iTrack™ canaloplasty microcatheter is intended for one time use only. DO NOT re-sterilize and/​or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

Precautions: The iTrack™ canaloplasty microcatheter should be used only by physicians trained in ophthalmic surgery. Knowledge of surgical techniques, proper use of the surgical instruments, and post-operative patient management are considerations essential to a successful outcome.

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